Accelerated Evolution Of Prostate Cancer Therapy Shaped Xtandi Review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Medivation/Astellas’ enzalutamide capped off an extraordinary three-year run in advanced castration-resistant prostate cancer therapy, with three successive NMEs each offering a greater survival advantage than the last. That accelerated evolution of new therapies created a complex context for FDA reviews.
You may also be interested in...
Does Imlygic Make The Case For FDA Oncology Center Of Excellence?
Products like Amgen's viral therapy for melanoma could benefit under proposals to replace FDA's modality-based organization with disease-specific centers. FDA's biologics center proved itself capable of reviewing the oncologic, but the drugs center already had extensive recent experience with the fast-changing melanoma market.
Medivation/Astellas Will Be Ready For Xtandi To Enter Pre-Chemo Prostate Cancer Setting
The oncology drug has been submitted for approval in the larger chemotherapy-naïve patient population and Medivation intends to increase its sales force to support the launch.
Deals Of The Week: Exit From Ambit Tie-Up Just A Blip In Astellas’ Oncology Aspirations
DOTW looks at Astellas’ oncology ambitions plus its recent split with partner Ambit, as well as analysis of Shire’s buyout of Premacure, AbbVie’s out-license of an anti-interleukin-13 antibody to Receptos and the Merck/Luminex collaboration on a companion diagnostic for Alzheimer’s disease.